The present invention relates firstly to a surgical device and secondly to a method for surgically treating urinary stress incontinence in women.
More particularly, the present invention relates to a device for percutaneous treatment of urinary stress incontinence in women using a synthetic sub-urethral tape.
For a long time, urinary stress incontinence has been treated under local, regional or general anesthetic, by supporting the urethra or bladder neck, in particular by using a tape.
U.S. Pat. No. 5,899,909 describes a method and a device for treating incontinence. The device enables a tape surrounded by a sheath to be implanted beneath the urethral canal, the sleeve then being withdrawn after implanting the tape. That device comprises two large needles located at either end of the tape-sleeve assembly, the needles comprising means on their proximal ends for mounting on a handle or a manipulator during the surgical intervention. Further, the tape-sleeve assembly is fixed to the proximal end using a plastic ring.
The tape is implanted by introducing each of the two needles in succession either side of the urethra, via an incision made in the anterior vaginal wall. Using each of the needles and holding them by the handle or introducing means fixed at its proximal end, the surgeon manipulates each needle to loop round the bladder and the pubic bone and exit via the abdominal wall in the suprapubic region.
The plastic sleeve surrounding the tape is presented cut at its centre and thus comprises two sections, the two sections overlapping, and the sleeve is thus removed by pulling on the ends of each of the sections which exit via each of the suprapubic cutaneous incisions.
That device and those known methods suffer from a number of disadvantages.
The device requires the use of an introducing means which has been specially designed for that type of surgical intervention. Further, the surgical intervention itself suffers from a major disadvantage in that the bottom-to-top track of the two large needles introduced into the anterior vaginal wall and exiting in the suprapubic region is not easy to control precisely, in particular when going around the base of the bladder, and vesical perforations are far from uncommon. This is upheld by medical publications. Thus it is recommended that a cystoscopy be performed during the intervention after passage of each needle. The use of that device also necessitates the use of a further accessory element, namely a rigid probe guide.
Those two accessories (introducing means and rigid guide) must thus be available to the surgical team for each intervention and has to be prepared by washing, packaging and serialization for each use.
Further, there is also a risk of vascular lesions which cannot be hidden: lateral passage with respect to the bladder with a vaginal point of entry runs the risk of injuring the epigastric and iliac vessels in the retrocrural region, with the points of the needles. Such lesions have already been recorded.
Finally for that method, if the cystoscopy confirms that the track of the tape-sleeve assembly is incorrect, it is very difficult to form a repeat track with the same device under suitable conditions. Reversing is difficult and exacting, not only for the tape-sleeve assembly, but also for the large needles. During these repetitive movements, the tape can often be uncovered due to the non hermetic nature of the sleeve. If the track is unsuitable, the sleeve-tape assembly has to be sectioned, for example at the needles, and the device can no longer be used properly for producing a further track.
Thus no percutaneous treatment exists for female urinary stress incontinence which uses a tape which can lead to the devices and technique of the present invention.
The present invention provides a method for treating urinary incontinence in a woman suffering from urinary stress incontinence, said method comprising at least the following steps:
a) forming an opening in the anterior vaginal wall;
b) creating, from two small suprapubic incisions formed in the abdominal skin, a right track and a left track from the abdominal skin to the opening formed in the anterior vaginal wall;
c) using a needle and an intermediate traction element to follow one of the tracks; and following the other with the needle and optionally an intermediate traction element;
d) verifying by cystoscopy that the path of these tracks is outside the bladder and the urethra;
e) using a support tape surrounded by a plastic sleeve to follow the tracks by passage under half of the inferior surface of the urethra;
f) adjusting the loop formed by the sleeved tape under the inferior surface of the urethra;
g) removing the sleeve by pulling towards the outside via the small abdominal incisions;
h) leaving the freed tape implanted from the first to the second incision, going round the urethra and serving to support the urethra.
It also provides a device for treating feminine urinary incontinence essentially constituted by:
a) a penetrating needle having a partially curved distal portion termed the active portion, which is integral with a straight portion having a proximal end;
b) a hermetically sleeved support tape having a distal end and a proximal end;
c) at least one intermediate traction element disposed between the penetrating needle and the sleeved tape, and having a proximal end and a distal end.
Thus the present invention overcomes the disadvantages of the known devices and methods by proposing a different operating technique and an original device which is suitable for implementing this method.
The operating technique of the invention is easier, faster and safer in particular as regards the vessels. The risk of vascular lesion does not exist because of the orientation and the given direction of the needle right from the start. The risk of vesical puncture is small even in the case of previous interventions in this regard, as is particularly frequent in this type of pathology. Using the device and operating method of the invention, the percutaneous route is used to form top-to-bottom tracks using the needle, i.e., penetrating via abdominal cutaneous mini-incisions to exit via a previously formed vaginal opening. Detachment of the vagina allows the index finger of the surgeon to be insinuated up to the lower rim of the pubis and thus enables the track of the needle to be precisely directed.
The device of the invention enables this track to be made from top to bottom on both sides and enables the absence of vesical puncturing to be confirmed by cystoscopy before engaging the sleeve-tape system.
Further, the device of the invention is capable of being re-used very readily in the event of introduction into the body along a track which proves not to be optimal, for either of the tracks. The risk of septic contamination of the sleeved tape generated by repeating manoeuvres can be removed. It should be noted that the need to re-form one of these tracks is a very rare event when using the present method, which only occurs. in the case of very strong adhesions of the bladder to the posterior surface of the pubis due, for example, to previous surgical interventions.